Real-world data of China: Analysis of HPV vaccine coverage and post-vaccination adverse reaction monitoring in Western Chinese provinces from 2018 to 2021

ABSTRACT

To investigate the HPV vaccine coverage and post-vaccination adverse reactions in Gansu Province, Western China, from 2018 to 2021. Data on suspected adverse reactions to HPV vaccines were collected from the Chinese Vaccine Adverse Event Following Immunization (AEFI). Estimate the incidence rates of Common Adverse Reaction and Rare Adverse Reaction. HPV vaccine coverage among females in different age groups was calculated using data from the Gansu Provincial Immunization Information Platform. The first-dose HPV vaccine coverage rate among females aged 9 to 45 was 2.02%, with the lowest rate of less than 1% observed in females aged 9 to 14. From 2018 to 2021, the incidence rates of Common Adverse Reaction and Rare Adverse Reaction reported in females after HPV vaccination were 11.82 and 0.39 per 100,000 doses, respectively. Common Adverse Reaction included fever (5.52 per 100,000 doses), local redness and swelling (3.33 per 100,000 doses), fatigue (3.15 per 100,000 doses), headache (2.76 per 100,000 doses), as well as local induration and nausea/vomiting (1.97 per 100,000 doses). Adverse reactions mainly occurred within 1 day after vaccination, followed by 1 to 3 days after vaccination. The HPV vaccine coverage rate among females aged 9 to 14 in Gansu Province is remarkably low, and there is an urgent need to enhance vaccine coverage. From 2018 to 2021, the incidence of Adverse reaction Following Immunization HPV vaccination fell within the expected range, indicating the vaccine’s safety profile.

KEYWORDS:

• Human papillomavirus vaccination
• cervical cancer
• vaccination coverage
• adolescent

Acknowledgments

We thank all study participants and the staff from the Lanzhou University.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Ethical approval

The study protocol and informed consent form were approved by the Medical Ethics Committee of the Gansu Provincial Center for Disease Control and Prevention (Approval notice: 2023019). Written informed consent was obtained from all study participants.

Abbreviations

HPV: Human papillomavirus; WHO: World Health Organization; AEFI: Adverse Events Following Immunization; GSK: GlaxoSmithKline; S. cerevisiae: Saccharomyces cerevisiae; Merck: Merck & Co., Inc.; RR: Relative Risk; CI: Confidence Intervals; N/V: Nausea/Vomiting; VAERS: Vaccine Adverse Event Reporting System; GACVS: Global Advisory Committee on Vaccine Safety.

Additional information

Funding

This study was funded by the Gansu Provincial Health Commission Research Project (GSWSQN2022-04) and the project sponsored by the Chinese Preventive Medicine Association to support young talents in the field of vaccines and immunization (CPMAQT_YM0310).